BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    VIZTEK WL

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PORTEX EPIFUSE EPIDURAL CATHETER CONNECTOR

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code CAZ·April 27, 2026

    PANORAMA CENTRAL STATION

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·September 16, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 17, 2011

    cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·June 20, 2018